NSCLC
Conditions
Interventions
furmonertinib:furmonertinib 160 mg orally once daily on an empty stomach.
Sponsors
The Fourth Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Obtain written informed consent from the patient. 2.Male or female patients, aged >= 18 years. 3.Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) with stage IV according to the IASLC 9th edition TNM staging, with adenocarcinoma or predominan adenocarcinoma components. 4.Positive for EGFR-sensitive mutations (19del and/or L858R mutations, which may occur alone or in combination). 5.Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2, with an expected survival of >= 12 weeks. 6.Patients who have not received prior systemic anticancer therapy for advanced/metastatic NSCLC. Patients who received adjuvant or neoadjuvant therapy (chemotherapy and/or radiotherapy) are eligible if no progression occurred within 6 months after treatment. Patients who received local therapy (radiotherapy or thoracic pleural perfusion therapy) are eligible if the lesions treated locally are non-target lesions. 7.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). 8.Patients with brain parenchymal metastasis or leptomeningeal metastasis diagnosed based on the "EANO-ESMO" diagnostic criteria for leptomeningeal metastasis. 9.Organ function must meet the requirements for treatment.
Exclusion criteria
Exclusion criteria: 1.Current concurrent malignancies other than NSCLC (excluding effectively controlled basal cell carcinoma of the skin, cervical carcinoma in situ, and ductal carcinoma in situ of the breast within the last 5 years). 2.Prior treatment with other EGFR-TKIs. 3.Known hypersensitivity to any active or inactive excipient of volmetinib or to drugs with similar structures or classes. 4.Breastfeeding women. 5.Unresolved toxicities from prior therapy with a Common Terminology Criteria for Adverse Events (CTCAE) grade >1 6.Patients deemed by the investigator to be unable to comply with the study protocol, constraints, and requirements (e.g., unlikely to adhere to study procedures or other reasons at the investigator's discretion).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| CNS PFS;ORR;DCR;CNS ORR;CNS DCR;Safety; | — |
Countries
China
Contacts
Public ContactDing Cuimin
The Fourth Hospital of Hebei Medical University
Outcome results
None listed